(66 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The intended use describes a simple pneumatic nebulizer accessory.
No.
The intended use describes the delivery of aerosolized medication, which implies it's a delivery mechanism for medication rather than a device that provides therapy itself.
No
The device is described as being "For use with pneumatic small volume nebulizers to deliver aerosolized medication," indicating it is a therapeutic device used for medication delivery, not for diagnosing conditions.
Unknown
The provided text only describes the intended use of the device, which is to be used with pneumatic small volume nebulizers. It does not contain any information about the device's description, components, or how it achieves its intended use. Therefore, it is impossible to determine if it is a software-only device based on this limited information.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use with pneumatic small volume nebulizers to deliver aerosolized medication." This describes a device used to administer medication to a patient, which is a therapeutic or drug delivery function, not a diagnostic function performed in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, based solely on the provided text, this device falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For use with pneumatic small volume nebulizers to deliver aerosolized medication.
Product codes
73 CAF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1998
Mr. S. David Piper Piper Medical Products 3929 Arderly Court Sacramento, Ca 95826
Re : K982408 AeroTee Regulatory Class: II (two) Product Code: 73 CAF September 4, 1998 Dated: Received: September 8, 1998
Dear Mr. Piper:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. S. David Piper
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
| 510(k) Number (if known): | K982408 |
|---|---|
| Device Name: | AeroTee™ |
| Indication for Use: |
For use with pneumatic small volume nebulizers to deliver aerosolized medication.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
ﺮ. Prescription Use : (Per 21 CFR 810.109)
ﮩﺮﺳ ﺳﺮ
Over-the-Counter Use ___________________
Marta Kramer
Division Sign. Division of Cardiov
(Optional Format 1-2-96)
INTNDUSE.DOC